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[Pharmaceutical Industry News] Following the official acceptance of the new drug marketing application (BLA) of BeiGene's PD-1 monoclonal antibody Baizean by the US FDA in September 2021, the product has recently received a marketing authorization application and was approved by the European Medicines Agency The good news accepted by (EMA) means that Baizean is accelerating the process of globalization
.
The indications accepted by the EMA are: for the treatment of patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC) and non-small cell lung cancer (NSCLC) patients who have previously received systemic chemotherapy
.
Among them, the relevant indications submitted for NSCLC include: monotherapy for adult patients with locally advanced or metastatic NSCLC after previous chemotherapy; as first-line therapy, combined with carboplatin and paclitaxel (or nab-paclitaxel) for local treatment Adults with advanced or metastatic squamous NSCLC; as first-line therapy in combination with pemetrexed and platinum-based chemotherapy in adults with locally advanced or metastatic non-squamous NSCLC without EGFR or ALK-positive mutations
.
Biozean is a humanized IgG4 anti-programmed death 1 (PD-1) monoclonal antibody designed to minimize binding to Fcγ receptors in macrophages
.
Preclinical data suggest that Fcγ receptor binding in macrophages subsequently activates antibody-dependent cell-mediated killing T cells, thereby reducing the antitumor activity of PD-1 antibodies
.
The MAA submission for ESCC is based on the results of a randomized, open-label, multi-center global Phase 3 trial RATIONALE302 (NCT03430843)
.
It is understood that the application for marketing authorization was filed by Novartis
.
In January 2021, BeiGene and Novartis announced a "marriage" whereby Novartis will jointly develop, produce and commercialize BeiGene in North America, Europe and Japan
.
Prior to this, the two parties also jointly promoted the FDA's acceptance of Bai Zean's new drug marketing authorization application
.
Up to now, Baizean has been approved for 7 indications in China, and another two new indications have been accepted by the National Medical Products Administration (NMPA) and are currently under approval
.
It is reported that BeiGene is also accelerating the global layout and clinical research of BeiGene
.
Up to now, Bai Zean has conducted or completed more than 20 clinical trials of the product with potential registration available in China and globally, including 17 Phase 3 clinical trials and 4 pivotal Phase 2 clinical trials
.
In addition, clinical trials of baizean in combination with other drugs are also underway, including ociperlimab, sitravatinib and zanidatamab
.
At present, PD-1 has become one of the most competitive markets in the pharmaceutical industry
.
According to Frost & Sullivan analysis data, the global PD-(L)1 inhibitor market will reach US$38.
1 billion in 2021 and is expected to reach US$63.
9 billion by 2023
.
In China, the market size of PD-(L)1 inhibitors is expected to reach 66.
4 billion yuan in 2023 and grow to 98.
8 billion yuan in 2030
.
The industry said that in the fierce competition for the stock market, in order to promote the growth of corporate performance, new indications, drug quality, production capacity, channels, sales teams and medical insurance have become the points of competition for companies
.
In 2021, Baizean has 3 new indications including first-line treatment of non-squamous non-small cell lung cancer (NSCLC), which will be included in the new version of the National Medical Insurance Catalogue.
In the context of the expansion of medical insurance reimbursement, the market penetration rate and market share of this product is also expanding
.
Data shows that in 2021, Bai Zean's sales in China have reached about 1.
6 billion yuan, a year-on-year increase of 56%
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
.
The indications accepted by the EMA are: for the treatment of patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC) and non-small cell lung cancer (NSCLC) patients who have previously received systemic chemotherapy
.
Among them, the relevant indications submitted for NSCLC include: monotherapy for adult patients with locally advanced or metastatic NSCLC after previous chemotherapy; as first-line therapy, combined with carboplatin and paclitaxel (or nab-paclitaxel) for local treatment Adults with advanced or metastatic squamous NSCLC; as first-line therapy in combination with pemetrexed and platinum-based chemotherapy in adults with locally advanced or metastatic non-squamous NSCLC without EGFR or ALK-positive mutations
.
Biozean is a humanized IgG4 anti-programmed death 1 (PD-1) monoclonal antibody designed to minimize binding to Fcγ receptors in macrophages
.
Preclinical data suggest that Fcγ receptor binding in macrophages subsequently activates antibody-dependent cell-mediated killing T cells, thereby reducing the antitumor activity of PD-1 antibodies
.
The MAA submission for ESCC is based on the results of a randomized, open-label, multi-center global Phase 3 trial RATIONALE302 (NCT03430843)
.
It is understood that the application for marketing authorization was filed by Novartis
.
In January 2021, BeiGene and Novartis announced a "marriage" whereby Novartis will jointly develop, produce and commercialize BeiGene in North America, Europe and Japan
.
Prior to this, the two parties also jointly promoted the FDA's acceptance of Bai Zean's new drug marketing authorization application
.
Up to now, Baizean has been approved for 7 indications in China, and another two new indications have been accepted by the National Medical Products Administration (NMPA) and are currently under approval
.
It is reported that BeiGene is also accelerating the global layout and clinical research of BeiGene
.
Up to now, Bai Zean has conducted or completed more than 20 clinical trials of the product with potential registration available in China and globally, including 17 Phase 3 clinical trials and 4 pivotal Phase 2 clinical trials
.
In addition, clinical trials of baizean in combination with other drugs are also underway, including ociperlimab, sitravatinib and zanidatamab
.
At present, PD-1 has become one of the most competitive markets in the pharmaceutical industry
.
According to Frost & Sullivan analysis data, the global PD-(L)1 inhibitor market will reach US$38.
1 billion in 2021 and is expected to reach US$63.
9 billion by 2023
.
In China, the market size of PD-(L)1 inhibitors is expected to reach 66.
4 billion yuan in 2023 and grow to 98.
8 billion yuan in 2030
.
The industry said that in the fierce competition for the stock market, in order to promote the growth of corporate performance, new indications, drug quality, production capacity, channels, sales teams and medical insurance have become the points of competition for companies
.
In 2021, Baizean has 3 new indications including first-line treatment of non-squamous non-small cell lung cancer (NSCLC), which will be included in the new version of the National Medical Insurance Catalogue.
In the context of the expansion of medical insurance reimbursement, the market penetration rate and market share of this product is also expanding
.
Data shows that in 2021, Bai Zean's sales in China have reached about 1.
6 billion yuan, a year-on-year increase of 56%
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
